Regulatory approval
Published by the Food and Drug Administration.
The U.S. Food and Drug Administration granted approval to midostaurin in combination with standard cytarabine and daunorubicin induction and cytarabine consolidation for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) that is FLT3 mutation-positive, as detected by an FDA-approved test. Midostaurin's product label notes that midostaurin is not indicated as a single-agent induction therapy for the treatment of patients with AML.
This is written in the approval document as:
RYDAPT is a kinase inhibitor indicated for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) that is FLT3 mutation- positive as detected by an FDA-approved test, in combination with standard cytarabine and daunorubicin induction and cytarabine consolidation. RYDAPT is not indicated as a single-agent induction therapy for the treatment of patients with AML.
Citation
Novartis Pharmaceuticals Corporation. Rydapt (midostaurin) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/207997s010lbl.pdf. Revised May 2023. Accessed October 30, 2024.Therapeutic response
Precision oncology relationships for therapeutic response derived from this regulatory approval.| Type | Biomarker(s) | Cancer type | Therapy(ies) | |
|---|---|---|---|---|
| Sensitivity (+) | FLT3-ITD | Acute Myeloid Leukemia | Cytarabine, Daunorubicin, Midostaurin | |
| Sensitivity (+) | FLT3 p.D835Y | Acute Myeloid Leukemia | Cytarabine, Daunorubicin, Midostaurin | |
| Sensitivity (+) | FLT3 p.D835A | Acute Myeloid Leukemia | Cytarabine, Daunorubicin, Midostaurin | |
| Sensitivity (+) | FLT3 p.D835E | Acute Myeloid Leukemia | Cytarabine, Daunorubicin, Midostaurin | |
| Sensitivity (+) | FLT3 p.D835H | Acute Myeloid Leukemia | Cytarabine, Daunorubicin, Midostaurin | |
| Sensitivity (+) | FLT3 p.D835N | Acute Myeloid Leukemia | Cytarabine, Daunorubicin, Midostaurin | |
| Sensitivity (+) | FLT3 p.D835S | Acute Myeloid Leukemia | Cytarabine, Daunorubicin, Midostaurin | |
| Sensitivity (+) | FLT3 p.D835V | Acute Myeloid Leukemia | Cytarabine, Daunorubicin, Midostaurin | |
| Sensitivity (+) | FLT3 p.I836del | Acute Myeloid Leukemia | Cytarabine, Daunorubicin, Midostaurin | |
| Sensitivity (+) | CDK12 oncogenic variants | Acute Myeloid Leukemia | Cytarabine, Daunorubicin, Midostaurin |